NDA 21822, held by Boehringer Ingelheim. Tipranavir.
As of Nov 14, 2026, NDA 21822 (Aptivus), held by Boehringer Ingelheim, was first approved by FDA on Jun 23, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2008 | Original applicationNew indication · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aptivus100MG/ML · solution; oral | Tipranavir | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters